Meltyy
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$Apple(AAPL.US$
👉 Key Highlights:
📍 Apple releases new iPad Air and iPad Pro, equipped with the powerful M2 chip.
📍 iPad Air now available in 11-inch and 13-inch models.
📍 Front-facing camera moved to landscape side for improved videoconferencing.
📍 Pricing starts at $599 for the smaller iPad Air and $799 for the larger model.
📍 First major update since October 2022, marking the longest interval between iPad releases.
📍 Devices to hit store...
👉 Key Highlights:
📍 Apple releases new iPad Air and iPad Pro, equipped with the powerful M2 chip.
📍 iPad Air now available in 11-inch and 13-inch models.
📍 Front-facing camera moved to landscape side for improved videoconferencing.
📍 Pricing starts at $599 for the smaller iPad Air and $799 for the larger model.
📍 First major update since October 2022, marking the longest interval between iPad releases.
📍 Devices to hit store...
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Meltyy
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See summary 👇
📣 4 PDUFAs upcoming in May:
$Dynavax Technologies(DVAX.US$ : 🤔
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Ascendis Pharma A/S(ASND.US$ : 🤔
⇒ YORVIPATH®
‣ hypoparathyroidism
‣ PDUFA date: 5/14/24 (NDA)
$Bristol-Myers Squibb(BMY.US$ : 🤔
⇒ Breyanzi®
‣ PDUFA dates: (sBLAs)
‣‣ 5/23/24 (r/r follicular lymphoma)
‣‣ 5/31/24 (r/r mantle cell lymphoma)
🗓️ Last week’s PDUFAs:
$X4 Pharmaceuticals(XFOR.US$ : Approved 4/29 🎉
⇨ XOLREMDI (mavorixafor)
‣ WHI...
📣 4 PDUFAs upcoming in May:
$Dynavax Technologies(DVAX.US$ : 🤔
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Ascendis Pharma A/S(ASND.US$ : 🤔
⇒ YORVIPATH®
‣ hypoparathyroidism
‣ PDUFA date: 5/14/24 (NDA)
$Bristol-Myers Squibb(BMY.US$ : 🤔
⇒ Breyanzi®
‣ PDUFA dates: (sBLAs)
‣‣ 5/23/24 (r/r follicular lymphoma)
‣‣ 5/31/24 (r/r mantle cell lymphoma)
🗓️ Last week’s PDUFAs:
$X4 Pharmaceuticals(XFOR.US$ : Approved 4/29 🎉
⇨ XOLREMDI (mavorixafor)
‣ WHI...
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Meltyy
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📣 3 PDUFAs left in April! See summary 👇
🗓️ Last week’s PDUFAs:
$Pfizer(PFE.US$ : Approved 4/26 🎉
⇨ BEQVEZ (fidanacogene elaparvovec-dzkt)
▹ Hemophilia B
▹ BLA
▹ PDUFA date: Q2 2024
$Day One Biopharmaceuticals(DAWN.US$ : Approved 4/23 🎉
⇨ OJEMDA (tovorafenib)
▹ Pediatric low-grade glioma
▹ NDA
▹ PDUFA date: 4/30/24
$ImmunityBio(IBRX.US$ : Approved 4/22 🎉
⇨ Anktiva + BCG
▹ Bladder cancer
▹ resubmitted BLA
▹ PDUFA date: 4/23/24
$Abeona Therapeutics(ABEO.US$ : CRL 4/22 🙁
⚠...
🗓️ Last week’s PDUFAs:
$Pfizer(PFE.US$ : Approved 4/26 🎉
⇨ BEQVEZ (fidanacogene elaparvovec-dzkt)
▹ Hemophilia B
▹ BLA
▹ PDUFA date: Q2 2024
$Day One Biopharmaceuticals(DAWN.US$ : Approved 4/23 🎉
⇨ OJEMDA (tovorafenib)
▹ Pediatric low-grade glioma
▹ NDA
▹ PDUFA date: 4/30/24
$ImmunityBio(IBRX.US$ : Approved 4/22 🎉
⇨ Anktiva + BCG
▹ Bladder cancer
▹ resubmitted BLA
▹ PDUFA date: 4/23/24
$Abeona Therapeutics(ABEO.US$ : CRL 4/22 🙁
⚠...
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Meltyy
liked
$Aquestive Therapeutics(AQST.US$ 📣 FDA Approves Libervant™ (Diazepam) Buccal Film
in Pediatric Patients Ages 2 to 5
⇨ 🥇 1st and only FDA approved orally administered rescue product
⇨ for Tx of seizure clusters (ages 2-5)
in Pediatric Patients Ages 2 to 5
⇨ 🥇 1st and only FDA approved orally administered rescue product
⇨ for Tx of seizure clusters (ages 2-5)
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Meltyy
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The FDA PDUFA Calendar is a chronological calendar of PDUFA target dates as well as Advisory meetings (ADCOMM). PDUFA target dates are dates by which the FDA aims to deliver their decision regarding an NDA or BLA filing. These decisions can however come before the PDUFA target date.
$Pfizer(PFE.US$ $Dynavax Technologies(DVAX.US$ $Sandstorm Gold(SAND.US$ $Bristol-Myers Squibb(BMY.US$ $SPDR S&P Biotech ETF(XBI.US$
$Pfizer(PFE.US$ $Dynavax Technologies(DVAX.US$ $Sandstorm Gold(SAND.US$ $Bristol-Myers Squibb(BMY.US$ $SPDR S&P Biotech ETF(XBI.US$
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Meltyy
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$Teva Pharmaceutical Industries(TEVA.US$ & alvotechpr
📣 FDA approves SELARSDI (Ustekinumab-Aekn), biosimilar to Stelara® 🎉
▻ approved for both adult and pedia indications (plaque psoriasis & psoriatic arthritis)
▻ developed and manuf. using same type of cells and process used for Stelara 👨🔬
▻ to be marketed in US on or after 02/21/25 🗓️
📣 FDA approves SELARSDI (Ustekinumab-Aekn), biosimilar to Stelara® 🎉
▻ approved for both adult and pedia indications (plaque psoriasis & psoriatic arthritis)
▻ developed and manuf. using same type of cells and process used for Stelara 👨🔬
▻ to be marketed in US on or after 02/21/25 🗓️
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Meltyy
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$Travere Therapeutic(TVTX.US$ Phase 3
$CG Oncology(CGON.US$ Phase 3
$United Therapeutics(UTHR.US$ Phase 3
$United Therapeutics(UTHR.US$ Phase 3
$BioCardia(BCDA.US$ Phase 3
$Insmed(INSM.US$ Phase 3
$GlycoMimetics(GLYC.US$ Phase 3
$Annexon(ANNX.US$ Phase 3
$Lipocine(LPCN.US$ Phase 3
$FibroGen(FGEN.US$ Phase 3
$UroGen Pharma Ltd(URGN.US$ Phase 3
$Lyra Therapeutics(LYRA.US$ Phase 3
$Citius Pharmaceuticals(CTXR.US$ Phase 3
$Jaguar Health(JAGX.US$ Phas...
$CG Oncology(CGON.US$ Phase 3
$United Therapeutics(UTHR.US$ Phase 3
$United Therapeutics(UTHR.US$ Phase 3
$BioCardia(BCDA.US$ Phase 3
$Insmed(INSM.US$ Phase 3
$GlycoMimetics(GLYC.US$ Phase 3
$Annexon(ANNX.US$ Phase 3
$Lipocine(LPCN.US$ Phase 3
$FibroGen(FGEN.US$ Phase 3
$UroGen Pharma Ltd(URGN.US$ Phase 3
$Lyra Therapeutics(LYRA.US$ Phase 3
$Citius Pharmaceuticals(CTXR.US$ Phase 3
$Jaguar Health(JAGX.US$ Phas...
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Meltyy
liked and voted
$Apple(AAPL.US$
👉 Key Highlights:
📍 Apple plans to overhaul its Mac lineup with new M4 processors, focusing on artificial intelligence.
📍 The M4 chip will come in three main varieties, targeting updates across all Mac models.
📍 Mac sales experienced a 27% decline last fiscal year, with efforts to rejuvenate the lineup via the M3 launch.
📍 Apple aims to compete in the AI space, seen as trailing behind Microsoft and Google.
📍 Launch t...
👉 Key Highlights:
📍 Apple plans to overhaul its Mac lineup with new M4 processors, focusing on artificial intelligence.
📍 The M4 chip will come in three main varieties, targeting updates across all Mac models.
📍 Mac sales experienced a 27% decline last fiscal year, with efforts to rejuvenate the lineup via the M3 launch.
📍 Apple aims to compete in the AI space, seen as trailing behind Microsoft and Google.
📍 Launch t...
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Meltyy
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$S&P 500 Index(.SPX.US$ climbs 0.9%, bouncing back from inflation concerns. $Nasdaq Composite Index(.IXIC.US$ surges 1.7%, with tech stocks driving gains. $Dow Jones Industrial Average(.DJI.US$ modestly up by 68 points or 0.2%.
Tech giants like $NVIDIA(NVDA.US$ and $Apple(AAPL.US$ lead with significant jumps. $Amazon(AMZN.US$ and $Alphabet-C(GOOG.US$ Alphabet also rally, boosting the tech sector.Apple enjoys its best day in 20...
Tech giants like $NVIDIA(NVDA.US$ and $Apple(AAPL.US$ lead with significant jumps. $Amazon(AMZN.US$ and $Alphabet-C(GOOG.US$ Alphabet also rally, boosting the tech sector.Apple enjoys its best day in 20...
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$Aditxt(ADTX.US$ to acquire Appili Tx
TuHURA Biosciences merger w/ $Kintara Therapeutics(KTRA.US$
$Johnson & Johnson(JNJ.US$ to acquire $ShockWave Medical(SWAV.US$
$Vertex Pharmaceuticals(VRTX.US$ to acquire $Alpine Immune(ALPN.US$
What companies will be next? 🤔
TuHURA Biosciences merger w/ $Kintara Therapeutics(KTRA.US$
$Johnson & Johnson(JNJ.US$ to acquire $ShockWave Medical(SWAV.US$
$Vertex Pharmaceuticals(VRTX.US$ to acquire $Alpine Immune(ALPN.US$
What companies will be next? 🤔
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